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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Medical Devices | Summer Recap 2020

Medical Devices | Summer Recap 2020

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Eurofins newsflash Medical Device

 

Regulatory news

 


 

France

 

Measures relating to the fight against the spread of COVID-19

 

Recently, the French authorities published several articles relating to masks in response to the COVID-19 pandemic. The publications are:

 

On other hand, the ANSM (Agence nationale de sécurité du médicaent et des produits de santé) published the following framework sheet in relation to 3D printing:

 

 

Recently, French authorities published several articles in relation to masks used in response to the COVID-19 pandemic. The publications include:

 

Other articles related to COVID-19:

 

 

Spain

 

Guidance in relation to mask and protective clothing manufacturing.

 

The Ministry of Industry, Commerce and Tourism has published new documents in relation to masks and protective clothing. Please see below a list of recent publications:

 

Overview:

 

  • Clarification of the different types of PPE and Health Products
  • >What mask do I need depending on my situation
  • List of all standards applicable to PPE and Medical Devices

 

Surgical masks:

 

  • Medical product type masks s; also known as surgical masks
  • Manufacturing process required to deem surgical masks as Medical Devices

 

Marketplace Spain Chamber:

 

  • Presentation-Summary - CE marking of EPI and PS products

 

Europe

 

Publications by the European Commission

 

Over the last number of months, the European Commission has published a variety of documentation, information and publications in relation to the use of medical devices during the COVID-19 pandemic. Please see below a summary table of all recent publications:

 

Official Journal of the European Union publications

Date

Reference

Title

16/03/2020

C/2020/1712

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

15/04/2020

C/2020/2391

Communication from the Commission Guidelines on COVID-19 in vitro diagnostic tests and their performance

24/04/2020

PE/10/2020/REV/1

Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 concerning medical devices with regard to the dates of application of some of its provisions 

19/05/2020

2020/C 171/01

Communication from the Commission Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745

19/05/2020

C/2020/3351

Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies

 

European Commission information and documents relevants

Date

Title

20/03/2020

Coronavirus: European standards for medical supplies made freely available to facilitate increase of production

20/03/2020

M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council

26/03/2020

New 2020 lists of harmonised standards for medical devices are now available

15/04/2020

Coronavirus: Commission issues guidelines on testing

27/04/2020

MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories

03-03-2020

Coronavirus: Commission issues questions and answers to help increase production of safe medical supplies

03-04-2020

Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

25-05-2020

How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context

01-07-2020

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC

08-06-2020

List of COVID-19 essential Medical Devices (MDs and IVDs)

23-07-2020

COVID-19 In Vitro Diagnostic Devices and Test Methods Database

13-07-2020

Conformity assessment procedures for protective equipment

02-07-2020

State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR (02/07/2020)

08-06-2020

Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices

23-07-2020

Guidance on regulatory requirements for medical face masks

Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic

 

For more information on medical device, please click here.

 

Standards updates

 

Please see the below table summarising the most recent standard updates and upcoming dates of withdrawal (non-exhaustive):

 

 (*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CENELEC / CEN

Reference

Title

Date of Withdrawal (*)

Supersedes

EN IEC 60118-13:2020

Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices

2023-02-19


EN 60118-13:2011

EN 17272:2020

Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities

2020-10-31

 

EN ISO 80601-2-56:2017/A1:2020

Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement - Amendment 1 (ISO 80601-2-56:2017/Amd 1:2018)

2023-05-31

 

EN 455-1:2020

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

2020-11-30

EN 455-1:2000

EN ISO 10993-18:2020

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

2020-11-30


EN ISO 10993-18:2009

 

EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)

2020-11-30


EN ISO 11737-2:2009

 

EN ISO 21850-1:2020

Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)

2020-11-30

 

EN ISO 7886-2:2020

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps (ISO 7886-2:2020)

2020-11-30


EN ISO 7886-2:1997

 

EN ISO 7886-3:2020

Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO 7886-3:2020)

2020-11-30


EN ISO 7886-3:2009

 

EN ISO/IEEE 11073-10201:2020

Health informatics - Device interoperability - Part 10201: Point-of-care medical device communication - Domain information model (ISO/IEEE 11073-10201:2020)

2020-12-31

EN ISO 11073-10201:2005

 

Regulatory updates

 

Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):

 

Countries

Notification number

Title

Hungary

2020/312/HU

Government Decree No 213/2020 of 16 May 2020 on the operation of cooling/heating systems in the state of emergency

France

2020/315/F

Draft Order of 20 May 2020 supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency

France

2020/318/F

Order supplementing the Order of 23 March 2020 prescribing the organisational and operational health system measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency

France

2020/329/F

Decree prescribing the general measures necessary to deal with the COVID-19 epidemic in the context of the state of health emergency

Sweden

2020/325/S

Regulations amending the Public Health Agency of Sweden’s Regulations (FoHMFS 2014:10) on alcoholic preparations

France

2020/402/F

Order applying the reduced rate of value added tax to protective equipment intended for combating the spread of the COVID-19 virus

Denmark

2020/515/DK

Order on special measures concerning the supply of disinfectants for the management of coronavirus disease 2019 (COVID-19).

Denmark

2020/511/DK

Order on special measures concerning the supply of medical devices and protective equipment for the management of coronavirus disease 2019 (COVID-19)

Denmark

2020/509/DK

Order amending the Order on medicinal product emergency response for the management of coronavirus disease 2019 (COVID-19)

 

US

 

Updates to face mask and respirator policy

 

In May 2020, the U.S. Federal Drug Administration (FDA) published the following revision to regulation on face masks used by the general public and respirators used by health care personnel (HCP):

 

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)

 

This document clarifies the use of face mask and N95 respirators which should only be used if they are FDA-cleared, FDA-authorised, or NIOSH-approved devices. The FDA has noted the importance of performing personalised fit testing.

 

Below you will find several letters and documents issued by FDA in relation to Emergency Use Authorization (EUA):

 

Guidance Documents and other regulatory guidance can be found on the FDA website.

 

International

 

Regulatory proposals notified to WTO

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/PER/120

Peru

Technical specifications for the manufacture of cloth face-masks for use by the community

The purpose of the present document is to establish technical specifications in order to lay out the design and manufacturing requirements for cloth face-masks for use by the community

G/TBT/N/CHE/245

Switzerland

Revision of the Ordinance No. 2 on Measures to Combat the Coronavirus (COVID-19)

The Articles 4l to 4o of the Ordinance No. 2 on measures to combat the coronavirus (COVID-19) introduce temporary exemptions to the authorisation and importation requirements for placing medicinal products on the market. Equally, temporary exemptions from the conformity assessment procedures for medical devices and personal protective equipment are introduced in these articles. The aim of these temporary exemptions is to ensure an adequate supply of medicinal products, medical devices and personal protective equipment during the COVID-19 pandemic

G/TBT/N/USA/1608

US

Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests

Proposed amendment; proposed order; request for comments - The Food and Drug Administration (FDA or Agency) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "hepatitis C virus (HCV) antibody tests" along with the special controls that the Agency believes are necessary to provide Reasonable assurance of the safety and effectiveness of these devices. The FDA is proposing this reclassification on its own initiative

G/TBT/N/USA/1602

US

Approval Tests and Standards for Air-Purifying Particulate Respirators

With this rulemaking, parallel performance standards are added to existing regulatory requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, that may be better suited to the needs of workers in the healthcare and public safety sectors currently experiencing a shortage of air-purifying particulate respirators due to Coronavirus Disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . This rulemaking also consolidates the technical standards for all types of air-purifying particulate respirators into one subpart, and standards pertaining to obsolete respirators designed for dust, fume, and mist; pesticide; and paint spray are removed from the regulation entirely. This rulemaking will have no substantive impact on the continued certification testing and approval by the NIOSH National Personal Protective Technology Laboratory of existing PAPR class HE (high-efficiency series) respirators or non-powered air-purifying particulate respirators, including N95 filtering facepiece respirators, currently in high demand by healthcare workers and emergency responders. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically for healthcare and emergency medical response settings

G/TBT/N/MAR/30

Moroco

Order of the Minister of Industry, Trade and the Green and Digital Economy No. 1060-20 of 14 Chaabane 1441 (8 April 2020) on protective masks of non-woven fabric for non-medical use

G/TBT/N/PER/123

Peru

Draft Regulation governing changes to medical devices in the sanitary register

 

UK

 

Transition period information

 

Please see the below table summarising the most recent publication made to UK authorities (non-exhaustive):

 

Date

Title

01-09-2020

Regulating medical devices from 1 January 2021

01-09-2020

MHRA post-transition period information

03-08-2020

Letter to medicines and medical products suppliers: 3 August 2020